VALIDATION STUDY PROTOCOL (OP0007) FOR THE EUROPEAN NON-INTERVENTIONAL POST- AUTHORIZATION SAFETY STUDY RELATED TO SERIOUS CARDIOVASCULAR EVENTS OF MYOCARDIAL INFARCTION AND STROKE AND ALL-CAUSE MORTALITY FOR ROMOSOZUMAB BY THE EU-ADR ALLIANCE (OP0004) AND EUROPEAN NON-INTERVENTIONAL POST-AUTHORIZATION SAFETY STUDY RELATED TO SERIOUS INFECTIONS FOR ROMOSOZUMAB BY THE EU-ADR ALLIANCE (OP0006)

Study type

• Study type:
  Not applicable
• If ‘Not applicable’, further details on the study type:
  Outcome validation study for real-world data
• If ‘other’, further details on the scope of the study:
  Validation of real-world data

Study drug and medical condition

• Name of medicine:
  EVENITY
• Study drug International non-proprietary name (INN) or common name:
  ROMOSOZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (M05BX) Other drugs affecting bone structure and mineralization

  Other drugs affecting bone structure and mineralization
• Medical condition to be studied:
  Osteoporosis postmenopausal

Population studied

• Age groups:
  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  250

Study design details

• Main study objective:
  The objective of this study is to determine the completeness and diagnostic validity of the following outcomes, which will be evaluated in the 2 European non-interventional PASS of romosozumab: 1. cardiovascular death, 2. myocardial infarction, 3. Stroke, 4. serious infection.
• Outcomes:
  Validation of 4 main outcomes in 2 PASS studies
• Data analysis plan:
  In patients eligible for each of 2 PASS studies, outcomes will be identified based on predefined code lists, which were adapted according to the relevant coding system for the respective databases. All validations (either sample or all-case validations) will be based on free text review of the individual cases. Primary care charts and any related documents (e.g. specialist letters, referrals) will be reviewed by clinically trained validators blinded to exposure. The algorithms for the validation of each of 4 outcomes is provided. Adaptations and specifications to the algorithm may be required to adapt the algorithm to database-specific needs.